Status:
COMPLETED
FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer
Lead Sponsor:
Sirtex Medical
Conditions:
Colorectal Cancer
Colorectal Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is a randomized multi-center trial that will assess the effect of adding Selective Internal Radiation Therapy (SIRT), using SIR-Spheres microspheres®, to a standard chemotherapy regimen of ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation.
- Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (Lung: 5 lesions total, \< 1 cm, or 1 single lesion of up to 1.7 cm; Lymph nodules in one single anatomic area (pelvis, abdomen or chest): any number, \< 2 cm).
- Suitable for either treatment regimen.
- Prior chemotherapy for metastatic colorectal cancer is not allowed.
- WHO performance status 0-1.
- Adequate hematological, renal and hepatic function.
- Age 18 years or older.
- Willing and able to provide written informed consent.
- Life expectancy of at least 3 months without any active treatment.
- Exclusion Criteria
- Evidence of ascites, cirrhosis, portal hypertension, main portal or venous tumor involvement or thrombosis as determined by clinical or radiologic assessment.
- Previous radiotherapy delivered to the upper abdomen.
- Non-malignant disease that would render the patient unsuitable for treatment according to the protocol.
- Peripheral neuropathy \> grade 1 (NCI-CTC).
- Dose limiting toxicity with previous adjuvant 5-FU or oxaliplatin chemotherapy.
- Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is not an exclusion criteria provided that it was completed more than 6 months before entry into the study.
- Pregnant or breast-feeding.
- Other active malignancy.
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
530 Patients enrolled
Trial Details
Trial ID
NCT00724503
Start Date
August 1 2006
End Date
May 1 2015
Last Update
March 26 2019
Active Locations (111)
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1
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States, 85258
2
City of Hope Hospital
Duarte, California, United States, 91010
3
Florida International University College of Medicine Practice
North Miami Beach, Florida, United States, 33169
4
Vanguard Health
Berwyn, Illinois, United States, 60402